Non-Steroidal Anti-Inflammatory Drug (NSAID)-induced small-intestinal injury Digestive System Small-intestinal injury
Conditions
Interventions
Rebamipide group: rebamipide 300 mg, diclofenac 75 mg and omeprazole 20 mg every day, thrice daily (t.i.d.) for two weeks
Placebo group: placebo, diclofenac 75 mg and omeprazole 20 mg every day, t.i.d
Sponsors
Individual Sponsor (Japan)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male sex 2. Aged at least 20 years 3. Body Mass Index (BMI) 18.5 - 25 kg/m^2 4. Lack of history of GastroIntestinal (GI) disorder 5. Japanese population 6. Healthy on examination by a physician 7. Subject able to comprehend and give informed consent for participation in this study 8. Signed informed consent form
Exclusion criteria
Exclusion criteria: 1. Active gastrointestinal disease 2. Use of ulcerogenic medications within two weeks before starting the study 3. Prior gastric or intestinal surgery 4. Pregnancy 5. Physician objection 6. Concurrent participation in any other clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the preventive effect of rebamipide for NSAIDs-induced small-intestinal mucosal brakes, evaluated by capsule endoscopy at time-course of day 0 and day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the preventive effect of rebamipide for NSAIDs-induced small-intestinal slight injuries, such as erythema and petechiae, evaluated by capsule endoscopy at time-course of day 0 and day 14. | — |
Countries
Japan
Outcome results
None listed